As surgical techniques have advanced, it has become increasingly common for surgeons to use specially designed hardware for the internal fixation of bones. A particular area of concentration for the recent development of this technology has been the spine. Internal fixation is used most frequently in the spine in conjunction with vertebral fusion, and also for the manipulation of the spine to correct spinal deformities such as scoliosis.
There are several important criteria for a hardware system which is used internally for spinal fixation:
1. The implant should provide rigidity as is indicated, generally along the long axis of the patient's spine.
2. The system should be able to accommodate a broad variation in the size and shape of the spinal member with which it is used. For example, the surgeon may wish to use the implant on a variety of individuals. In addition, the difference in the area and size of the point of fixation is compounded by the change in the shape of the vertebrae over the length of the full spinal column. Since it is an advantage to allow the surgeon to master implanting a particular type of assembly, it is preferable if the same or similar anchoring means can be used for a variety of locations. This advantage results in cost efficiency of inventory as well as efficiencies with respect to minimizing the operating time.
3. The hardware must be able to apply and oppose considerable stresses and strains. Thus, the anchor means must be securely fixed to the bone, and the stabilizer must be securely fixed with regard to the anchor means. Moreover, it is desirable to provide the hardware with the integrity to resist breaking.
4. The system should be designed for ease of implantation and removal. Implant hardware is relatively small and therefore somewhat difficult to manipulate. Any difficulty with assembly is compounded by the fact that the assembly occurs during surgery and in a living being. Therefore, it is critical that the hardware is designed with the surgeon's convenience in mind, i.e., to limit the time required and the stress required to implant an assembly. Consequently, a fixation system should be designed to the extent possible for easy assembly while maintaining the option of removal where necessary.